Conical portio adapter — Class II medical device recall Z-2608-2016

Terminated recall by Richard Wolf Medical Instruments Corp., reported 2016-08-31, distributed in AK, AL, AR, AZ, CA, CT, DC, FL…. The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits ins

Recall number	`Z-2608-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Richard Wolf Medical Instruments Corp., Vernon Hills, IL, United States
Recall initiated	2016-05-19
Classified	2016-08-19
Reported by FDA	2016-08-31
Terminated	2017-11-30
Distributed	AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT, VA
Lot numbers	`51005921`, `51005922`

Product

Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.

Reason for recall

The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2608-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.